Last time I updated on my husband he had resumed chemo, was going to try one more round before traveling to St Louis for Provenge at Siteman Center, and then I as hopeful to get into the reformulated Checkmate 650, which was stopped due to unacceptable toxicity levels...I definitely get why now! What actually happened: Joe did not get any more chemo, because he was just too sick. They went ahead and started (and have now completed) Provenge. Didn’t do anything to except give him what I believe was false hope. Keep in mind- during all of this time- from 7/8 months ago until now his cancer is spreading through his vertebrae and pelvis - more every scan. His PSA doubling time is 1 month. The chemo did get that down to 1 or 2 something but he’s at 38.8 as of last week. The reformulated trial reopened and Joe had one treatment two weeks ago. He’s getting both drugs- Ipilimumab and Nivolumab. The schedule is 4 treatments three weeks apart, and then Ipilimumab every 4 weeks for up to two years.
One treatment in and two days later was in the hospital for colitis. Discharged after a day. They called it a grade 2 adverse event so he can continue the trial. Great! 5 days later woke up with excruciating flank pain at 2am. First time ever wanted me to call the doctor, first time I thought I might have to call an ambulance. They did a scan and labs and his blood counts are wonky- rbc’s, hemocrit, hemoglobin trending down every time - this scares the hell out of me because of past bone marrow metastasis and history of disseminated intravascular coagulation (DIC) at diagnosis in August 2017. Low calcium. Very low bun:creatinine ratio. CT didn’t show anything (other than more bone cancer) and he was admitted for pain control and discharged little more than a day later but he’s still having constant pain there- though obviously the intensity is much lower. His skin has broken into a horrific rash with pustules- looks awful and itches him like crazy. But they want to give him another treatment next Wednesday! He looks at the trial physician as his additional oncologist...but it sure seems like a conflict of interest to me. He’s doing everything to keep Joe in a trial that I feel strongly will only shorten his life- and he continues to be positive about it when he talks to my husband! Our oncologist here in Dallas told me privately he agreed this trial wasn’t good for Joe...but he won’t tell Joe that bc he won’t crush his hope. I’m so frustrated I could scream. I do think- for a small subset of mcrpc patients with certain bio markers- this could potentially truly be unbelievably helpful...but they need people without those markets to show that- and I think my husband is being used basically as a control. I am so over here this physician, this trial, the traveling for this trial that takes him away from our kiddos- this is him with out second to youngest who is 8. How can anyone justify not being bluntly honest with someone about the likelihood of results when they are leaving their children for it??? There’s my venting. Lost 2 friends to cancer within the last two weeks as well which hasn’t helped. Just in a really shitty cancer place. Hating this disease and wishing oncologists had much, much more training in how to deal with patients emotionally. If you read all this- thank you for hearing my frustration. Hope all of you are in a more positive place- I usually am. Maybe tomorrow!
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joekaty
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Yeah, the initial results of the combo test of the first Checkmate 650 trial were disappointing. There was some response (in 25% of pre-chemo men and 10% of post chemo men) from the combination, but no response from either drug alone in earlier trials. However, all of the responders (60% of the pre-chemo group and 40% of the post-chemo group) had a high mutational burden and/or showed the presence of PD-L1 in the tumors (33% of the pre-chemo group and 19% of the post chemo group). Conversely, none of the men who had low mutational burden or no PD-L1 tumors had any response to the combination therapy. Toxicity was unacceptably high, which is why they reformulated the mix. But even apart from toxicity concerns, the early data indicate that the cancer must evolve to a high degree of genetic breakdown before such therapies become effective. Early use causes unacceptable toxicity without any survival benefit.
I'm sort of surprised they took him with previous Provenge therapy. They specifically exclude people who have had "Prior treatment with any drug that targets T cell co-stimulation pathways." It isn't surprising that he would have autoimmune reactions.
Yep. Joe has very low tumor mutational burden. It was 2. No PD-L1 presence. The irony is that the only reason I was remotely supportive because was because I knew he couldn’t tolerate any more chemo...but now I would take chemo over these side effects any day. He’s up now with excruciating neck/head pain, blurred vision. It’s been horrific and I frankly can’t believe they’re going to let him have another dose but they are and I’m just preparing for more hospital visits. Don’t think the reformulation has reduced toxicity- at least in his trial “arm”- D1.
I realized I had misread your statement about Provenge. I hadn’t really thought about that but you are absolutely right and I’ll have to get out the paperwork but I think it’s specifically excluded. Its also not surprising because he had already been hospitalized in June for a week with colitis, he already has dermatological issues...I pretty much knew that colitis would be the biggest and first problem and it was, and now I feel sick thinking about him getting another treatment when he hasn’t recovered from the first.
If in your shoes, I think I would want to print out and to read this Full Prescribing Information for Ipilimumab (Yervoy), with or without Nivolumab (Opdivo), along with all the Warnings, Precautions, Adverse Events, Rescue Treatments, Dose Adjustments, etc., and to know it very intimately while having discussions with his doctors and/or clinical trial monitors.
Thank you Charles. I am intimately familiar with them unfortunately. My husband just doesn’t want to know anything about them. He wants at least one more treatment but I feel like even one more could just be so incredibly harmful and at this point is more dangerous to him then his cancer. The irony...
So I actually had not seen that specific insert and it was helpful. His body rash sounds pretty exactly as what they describe as being possibly fatal, and ocular symptoms are mentioned which he has also been having. Very helpful! Thank you!
Many types of information can be helpful. FYI, back in 2013 I was offered a clinical trial at UCSF consisting of Provenge, closely followed by Ipilimumab. I learned at that time that UCSF, Dr. Eric Small and his colleagues had some depths of experience at doing "rescue" interventions, typically involving lots of steroids, when Ipilimumab adverse events started going south in some of the initial clinical trials. In my case, I decided against doing the "Ipi" at that time because I had a few other things happening, and I did not want to pile on the potential side effects. In your case, I was thinking that it might be helpful if your doctor should want to pick-up the phone and give the UCSF folks a call in the event of any undue adverse events or side effects involving "Ipi", and shared expertise in conducting a "rescue" intervention, if needed. I would think that Eric Small, Lawrence Fong, or Rahul Aggarwal would all be good for such consultations or second opinions regarding "Ipi" management matters. Various numbers and emails are available at the usual UCSF web links, e.g.
Charles, Thank you so very much. It is weird with the steroids. Our local oncologist told us to make sure he wasn’t given steroids in the hospital, but trial oncologist administering the Ipi recommended them. In the end he did take them. Not sure if it made things better or worse but as he had more experience our local MO suggested deferring to him. Thank you for the info. I feel I can never have enough!
Oh! Best wishes to you and your husband! I do think the doctor-patient changes in the clinical trials. The doctor becomes more concerned about meeting study protocols then managing what is going on with the patient. So sorry for the pain you guys are going through. It does sound just awful, Thinking of you and thanks for posting.
It certainly feels no win right now. Germany isn’t out of the question but bc of his medical history and particularly bone marrow metastasis my understanding has been that it would not be a good treatment choice for him. I’m light of where we are now though- worth revisiting!
Sometimes the lemons come so fast that it is hard to keep up with the lemonade making. I'm praying for a quick turnaround for Joe...and for you. I keep him (and you) in my thoughts 🌷
I cannot imagine how impossible this all Is for you and your family.
It sounds like you are operating on facts (treatment is not working based on objective data and to continue may harm him further) and he is operating on feelings (hope that something will change, fear of leaving wife and kids)
I am
Much earlier on in the struggle with my
Husband (diagnosed in May 2019) but so far nothing seems to work the way it is supposed to. It’s been a lot of mostly bad news for us.
Clearly you want your husband to keep on living and clearly he wants that too. One of the questions that we must answer in life (although we are mostly never prepared to do it) is at what cost do we continue?
I pray that your situation shifts. You are a very strong person and will get through Whatever life has coming.
Very perceptive and very true re: how we are operating. The “at what cost” question is so hard. We did meet with palliative care at his last hospitalization and I think it was helpful for him to realize there is better symptom management available. I would probably prefer we reduce treatment and he have higher quality of life even if his length of life was shortened somewhat. Blunt, but true. He thinks he can have it all. I’m trying to take a backseat and let him take the wheel right now but it’s hard.
Thinking of your family and you as you begin this journey. The one thing I try to share is that as painful as things have been- like, truly brutal...we’ve had 10 beautiful moments for every awful one and that’s something for which I will be eternally grateful.
I delt with those Dermatological issues that lasted all summer sounds familiar pustular and turns into raw areas that burn unless covered. Three doctors had no reasonable solution. Best diagnosis was drug induced lupus. What finally cleared it up was 60 mg of prednisone and an daily antibiotic wash and 10 days of doxycycline. Good luck and get ahead od the skin issues. I think that pressure to the area heat and sweat contributed. Very painful on buttocks and torso.
Yes! Sounds very familiar. Worried about it leading to sepsis so trying to stay on top of it. I’m so sorry you experienced that but thank you for sharing your experience.
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